When does outsourcing autologous collection center qualification and the cell therapy supply chain make sense?

Discover actionable solutions to streamline your supply chain and improve patient outcomes.

The first autologous CAR-T therapy was approved in 2017, and the industry has since gained substantial operating experience, treating tens of thousands of patients globally. Some drug sponsors have developed in-house teams to manage, improve, and maintain the infrastructure needed for these complex therapies, while others have opted to outsource these responsibilities. The supply chain for autologous CAR-T therapies has been a focus of improvement since the early trials, especially the transport of cells. Significant investments have aimed to make the supply chain more predictable and reliable.

While outsourcing the supply chain to a single logistics supplier is now more feasible, active management of the supply chain remains crucial for maintaining quality and efficiency. Managing this task internally may lead to inefficiencies, especially when compared to using partners experienced in onboarding centers for multiple clients. However, some drug sponsors prefer to manage collection center qualification internally due to the specific protocols required for each autologous CAR-T therapy, ensuring tighter control over standards and processes.

IntegriCell™ cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. Our state-of-the-art cryopreservation process, integrated with our end-to-end global temperature-controlled supply chain platform, provides unmatched reliability, efficiency, and scope.